1.0 OBJECTIVE

The main objective of this protocol is to validate the method of Personnel Gowning procedure.

2.0 SCOPE

This protocol shall be applicable to the Critical area of Microbiology laboratory and Production department.

3.0 RESPONSIBILITY

The responsibilities of different departments involved in the execution of this validation.
Executive – Microbiology
In-charge – Microbiology

4.0 ACCOUNTABILITY

In-charge – Quality Assurance

5.0 PROCEDURE

5.1 Materials and Equipment used

Dehydrated media: Soybean Casein Digest Agar.

RODAC Plates.

Incubators 20-25 °C and 30-35 °C.

Sterilized garments and gloves

5.2 Pre Validation Checks

Ensure that the used media qualified for Growth promotion test and Preincubation test.

Training shall be given to the personnel who is entering the aseptic area as per Entry and Exit SOP of the respective area. A training report shall be attached.

A gowning demonstration shall be taken in presence of Microbiologist or Manufacturing head as applicable.

5.3 Validation Procedure

5.3.1 Exercise-I

5.3.1.1 Personal Monitoring by Contact plate (RODAC) technique

The Personnel shall enter in the aseptic area along with the microbiologist

Personnel and Microbiologist shall enter into the aseptic area as per current SOP of entry and exit to the Microbiology and Production area.

Monitoring shall be done in Exit Airlock of the Critical area

For personnel, monitoring open the prepared RODAC contact plate and gently press the convex surface on the area to be tested and close the lid immediately.

5.3.1.2 Monitoring shall be done for

Armpits left and right

Chest's left and right

Shoulder's left and right

Elbows left and right

Waist

Thighs left and right

Finger Dab left and right

5.3.1.3 Immediately after sampling, remove the gown and gloves. Label the plates with name, the location of sampling, area and date; incubate at 20-25 °C for 72 hrs and at 30-35 °C for a further 48 hrs.
5.3.1.4 After incubation, count the number of colonies on each plate and record the number of colonies as cfu/contact plate in Personnel Monitoring Report.
5.3.1.5 Individual person shall be monitored consecutively 3 days.
5.3.1.6 If the personnel found to fail in gowning qualification the personnel shall be trained for gowning qualification and shall be re-monitored.
5.3.1.7 Personnel monitoring shall be done in Exit Airlock-1 of the Microbiology laboratory/production aseptic area.
5.3.2 Exercise-II
5.3.2.1 Personal Monitoring by Contact plate (RODAC) technique:
5.3.2.2 The Personnel shall enter in the aseptic area along with the microbiologist.
5.3.2.3 Personnel and Microbiologist shall enter into the aseptic area as per current SOP of entry and exit to the Microbiology and Production area.
5.3.2.4 Monitoring shall be done in Exit Airlock of the Critical Area.
5.3.2.5 For personnel monitoring open the prepared RODAC contact plate and gently press the convex surface on the area to be tested and close the lid immediately.
5.3.2.6 Monitoring shall be done for

Armpits left and right

Chest's left and right

Shoulder's left and right

Elbows left and right

Waist

Thighs left and right

Finger Dab left and right

5.3.2.7 Immediately after sampling, remove the gown and gloves. Label the plates with name, the location of sampling, area and date; incubate at 20-25°C for 72 hrs and at 30 – 35 °C for a further 48 hrs.
5.3.2.8 After incubation, count the number of colonies on each plate and record the number of colonies as cfu/contact plate in Personnel Monitoring Report.
5.3.2.9 Individual person shall be monitored consecutively 3 days.
5.3.2.10 If the personnel found fail in gowning qualification the personnel shall be trained for gowning qualification and shall be monitored.
5.3.2.11 Personnel monitoring shall be done in Exit Airlock-1 of the Microbiology laboratory/production aseptic area.

5.3.3 Exercise III
5.3.3.1 Personal Monitoring by Contact plate (RODAC) technique:
5.3.3.2 The Personnel shall enter in the aseptic area along with the microbiologist.
5.3.3.3 Personnel and Microbiologist shall enter into the aseptic area as per current SOP of entry and exit to the Microbiology and Production area.
5.3.3.4 Monitoring shall be done in Exit Airlock of the Critical Area.
5.3.3.5 For personnel monitoring open the prepared RODAC contact plate and gently press the convex surface on the area to be tested and close the lid immediately.
5.3.3.6 Monitoring shall be done for

Armpits left and right

Chest's left and right

Shoulder's left and right

Elbows left and right

Waist

Thighs left and right

Finger Dab left and right

5.3.3.7 Immediately after sampling, remove the gown and gloves. Label the plates with name, the location of sampling, area and date; incubate at 20-25°C for 72 hrs and at 30 – 35 °C for a further 48 hrs.
5.3.3.8 After incubation, count the number of colonies on each plate and record the number of colonies as cfu/contact plate in Personnel Monitoring Report.
5.3.3.9 Individual person shall be monitored consecutively 3 days.
5.3.3.10 If the personnel found to fail in gowning qualification the personnel shall be trained for gowning qualification and shall be monitored.
5.3.3.11 Personnel monitoring shall be done in Exit Airlock-1 of the Microbiology laboratory/production aseptic area.
5.3.4 Positive control
Perform Soybean casein digest Agar GPT with S. aureus ATCC 6538, Incubate at 30-35°C for 48 hrs and Candida albicans ATCC 10231/ Aspergillus niger ATCC 16404, Incubate at 20-25 ºC for 5 days.
5.3.5 Negative control
Make a negative control for each exercise by pressing the sterile swab on RODAC plate.
5.3.6 Acceptance criteria:
5.3.6.1 The positive control shall show growth within 72 hrs.
5.3.6.2 The negative control should not show growth.
5.3.6.3 Contact plate limit:

Grade

Gloves

Personnel Gown

A

<1

5

B

5

5

Finger Dab: Grade A=<1, B=05cfu/plate
Gowns: 05 cfu/plate

5.4 Frequency
Whenever new personnel joined in the Microbiology laboratory/ manufacturing area shall be qualified prior to entering in aseptic area. Requalification shall be performed once in a year.